Support

Take advantage of the CHOLBAM® Total Care Hub patient support program

CHOLBAM® Total Care Hub: about the patient support program
The CHOLBAM® Total Care Hub is a comprehensive support program for patients who have been prescribed CHOLBAM® (cholic acid) capsules and their caregivers. When you enroll in the program, a dedicated Hub Counselor will be assigned to you.

Your Access Hub: Financial support and reimbursement options

Access hub

  • Your Hub Counselor will work with your insurance company on benefit verification, prior authorizations, and appeals
  • By partnering with your doctor’s staff, your Hub Counselor will help organize relevant documentation throughout your treatment
  • Co-payment assistance or other financial support may be available for eligible patients

Your Delivery Hub: Convenient home delivery and prescription refills

Delivery hub

  • Your Hub Counselor will coordinate convenient home delivery that will save you trips to the pharmacy and help you stay on schedule with your medication so that you never miss a CHOLBAM® dose
  • Tips and updates about your treatment are available through your Delivery Hub

Your Support Hub: Receive live, on-demand support

Support hub

  • Your Hub Counselor can answer questions about your treatment and set up appointment reminders to help you stay organized and on track
  • The Hub is available 24 hours a day, 7 days a week

Your Education Hub: Learn more about managing your condition and treatment

Education hub

  • You can opt in to receive emails and brochures with updates and information about your CHOLBAM® treatment
  • You can learn about support groups where you can connect with others
  • Be sure to talk to your doctor if you have concerns or issues about your treatment or side effects

Join the CHOLBAM® Total Care Hub with just 3 simple steps

  • STEP 1: Download and complete the CHOLBAM® Total Care Hub enrollment form. The CHOLBAM® Total Care Hub enrollment forms have sections for the patient and doctor to complete. If you have any questions or need help completing the form, call 844.CHOLBAM (844.246.5226)
  • STEP 2: Your doctor faxes the enrollment forms to the Hub. Once the appropriate signatures are obtained, your doctor can return the form by faxing it to 877.473.3171
  • STEP 3: Complete enrollment and schedule your first CHOLBAM® shipment. Once the CHOLBAM® Total Care Hub has received the completed enrollment forms, they will call the patient to complete the enrollment process. At this time, they will schedule the first CHOLBAM® shipment

Call 1-844-CHOLBAM (1-844-246-5226) to learn more

Indication and Usage
CHOLBAM® is a bile acid indicated for:

  • Treatment of bile acid synthesis disorders due to single enzyme defects
  • Adjunctive treatment of peroxisomal disorders including Zellweger spectrum disorders in patients who show signs and symptoms of liver disease, steatorrhea (fatty stools), or complications from decreased fat soluble vitamins absorption (A, D, E, K)

Limitation of Use:
The safety and effectiveness of CHOLBAM® on extrahepatic manifestations of bile acid synthesis disorders due to single enzyme defects or peroxisomal disorder including Zellweger spectrum disorders have not been established.

Important Safety Information
Warnings and Precautions—Exacerbation of Liver Impairment

  • Monitor liver function and discontinue CHOLBAM® (cholic acid) in patients who develop worsening of liver function while on treatment.
  • Monitor AST, ALT, GGT, alkaline phosphatase, bilirubin, and international normalized ratio (INR) every month for the first 3 months, every 3 months for the next 9 months, every 6 months during the next 3 years and annually thereafter. Administer the lowest dose that effectively maintains liver function.
  • Discontinue CHOLBAM® if liver function does not improve within 3 months of starting treatment, if complete biliary obstruction develops, or if there are persistent clinical or laboratory indicators of worsening liver function or cholestasis; continue to monitor liver function and consider restarting at a lower dose when parameters return to baseline.

Adverse Reactions
In the CHOLBAM® clinical trials, diarrhea was the most common adverse reaction in approximately 2% of the patient population. All other adverse reactions are less than or equal to 1% of the patient population.

Drug Interaction

  • Bile Salt Efflux Pump (BSEP) Inhibitors (eg, cyclosporine): Avoid concomitant use; if concomitant use is necessary, monitor serum transaminases and bilirubin.
  • Bile Acid Resins and Aluminum-Based Antacids: Take CHOLBAM® at least 1 hour before or 4 to 6 hours (or at as great an interval as possible) after a bile acid binding resin or aluminum-based antacids.

Pregnancy
No studies in pregnant women or animal reproduction studies have been conducted with CHOLBAM®. Women who become pregnant during CHOLBAM® treatment are encouraged to call 1-844-202-6262.

Lactation
Endogenous cholic acid is present in human milk. Clinical lactation studies have not been conducted to assess the presence of CHOLBAM® in human milk, the effects of CHOLBAM® on the breastfed infant, or the effects of CHOLBAM® on milk production.

There are no animal lactation data and no data from case reports available in the published literature.

Overdosage
In the event of overdose (elevated GGT and ALT), the patient should be monitored and treated symptomatically.

Elevated serum gamma glutamyltransferase (GGT) and serum alanine aminotransferase (ALT) may indicate CHOLBAM® overdose. Continue to monitor laboratory parameters of liver function and consider restarting at a lower dose when the parameters return to baseline.

Please see full prescribing information for CHOLBAM® (cholic acid) 50 mg and 250 mg capsules.

To report SUSPECTED ADVERSE REACTIONS, contact Retrophin, Inc. at 1-877-659-5518 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.